Linaclotide (lin-AK-loe-tide)

Treats irritable bowel syndrome with constipation and chronic idiopathic constipation.

Brand Name(s):

Linzess

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine on an empty stomach, at least 30 minutes before breakfast or your first meal of the day.
• Swallow the capsule whole. Do not crush, break, or chew it.
• If you have trouble swallowing the capsule, you may mix the contents with applesauce or water.
  • To mix with applesauce: Open the capsule and sprinkle the beads on 1 teaspoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use.
  • To mix with water: Open the capsule and sprinkle the beads into a cup with 30 mL (1 ounce) of water. Swirl the mixture for at least 20 seconds. Swallow the mixture right away. If there are beads remaining in the cup, you may repeat the same procedure. Do not store the mixture for future use.
  • You may also take the bead-water mixture using a nasogastric or gastric feeding tube. After the mixture is given, flush the tube with an additional 10 mL (2 teaspoons) of water.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in the original bottle until you are ready to use it. The bottle contains a desiccant packet that helps protect the capsules from moisture. Do not remove the packet from the bottle.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have other stomach or bowel problems.
• This medicine may cause severe diarrhea.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Lightheadedness, dizziness, fainting
• Severe diarrhea or stomach pain

If you notice these less serious side effects, talk with your doctor:

• Mild diarrhea, passing gas, full or bloated feeling
• Stuffy or runny nose, sneezing

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088